Perrigo Announces FDA Approval Of The Generic Version Of Ofirmev® Acetaminophen Injection
DUBLIN, June 16, 2016 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received final U.S. Food and Drug Administration ("FDA") approval for the generic version of Mallinckrodt Pharmaceuticals' Ofirmev® (acetaminophen) injection 1000 mg/100 mL.
As previously announced, Perrigo can launch a generic version of Ofirmev® (acetaminophen) injection on December 6, 2020, or earlier under certain circumstances. In addition, Perrigo has secured the right to be the sole authorized generic distributor should Mallinckrodt elect to launch an authorized generic product.
Ofirmev® (acetaminophen) injection 1000 mg/100 mL is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever. Branded sales for the twelve months ending April 2016 were $275 million.
Perrigo's CEO John T. Hendrickson stated, "This product approval demonstrates the strength of Perrigo's Rx portfolio. Approvals in difficult formulations like this are what drive Perrigo's diverse product portfolio, which continues to provide a unique offering to our customers around the world."
Perrigo Company plc, a top five global over-the-counter ("OTC") consumer goods and pharmaceutical company, offers patients and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of generic home remedies, Perrigo, headquartered in Ireland, has grown to become the world's largest manufacturer of OTC products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products and receives royalties from Multiple Sclerosis drug Tysabri®. Perrigo provides Quality Affordable Healthcare Products® across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other markets, including Israel, China and Latin America. Visit Perrigo online at (http://www.perrigo.com).
Certain statements in this press release are "forward-looking statements." These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control, including the timing, amount and cost of share repurchases, future impairment charges, our ability to achieve our guidance and the ability to execute and achieve the desired benefits of announced initiatives. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-KT for the six-month period ended December 31, 2015, and form 10-Q for the quarter ended April 2, 2016 as well as the Company's subsequent filings with the SEC, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Perrigo Company plc
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